Recall events
/
Event 91021
Event summary
Timeline bucket October 17, 2022
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording ARROW INTERNATIONAL Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
31 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Z-0426-2023
Recall number Z-0426-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 1394 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0426-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58404]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 05172 1, (01) 0 0801902 05172 2, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32774]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
Z-0427-2023
Recall number Z-0427-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0427-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27984]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09375 2, (01) 0 0801902 09375 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33815]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Z-0428-2023
Recall number Z-0428-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 12 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0428-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33718]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 05174 5, (01) 0 0801902 05174 6, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35860]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
Z-0429-2023
Recall number Z-0429-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 2678 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0429-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51847]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 05171 4, (01) 0 0801902 05171 5, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33773]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
Z-0430-2023
Recall number Z-0430-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 88 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0430-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27970]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09391 2, (01) 0 0801902 09391 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36157]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Z-0431-2023
Recall number Z-0431-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 81 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0431-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45479]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 05173 8, (01) 0 0801902 05173 9, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35765]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Z-0432-2023
Recall number Z-0432-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0432-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28002]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 05173 8 (11) 170825 (21) 999999W, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36435]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Z-0433-2023
Recall number Z-0433-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0433-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9959]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 08495 8, (01) 0 0801902 08495 9, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36068]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 31
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
Z-0434-2023
Recall number Z-0434-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0434-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45460]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 2 0801902 17208 6, (01) 2 0801902 17208 9, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36558]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0435-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0435-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4710]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09118 5, (01) 0 0801902 09118 6, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35956]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0436-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0436-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4738]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 2 0801902 18177 4, (01) 2 0801902 18177 7, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32862]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0437-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0437-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45477]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 2 0801902 17209 3, (01) 2 0801902 17209 6, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35337]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0438-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0438-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27985]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 08496 5, (01) 0 0801902 08496 6, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33633]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0439-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0439-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27994]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 2 0801902 17206 2, (01) 2 0801902 17206 5, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32872]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0440-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0440-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4706]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 2 0801902 14277 5, (01) 2 0801902 14277 8, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35343]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0441-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0441-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16655]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09125 3, (01) 0 0801902 09125 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32889]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0442-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0442-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21816]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 1 0801902 18178 4, (01) 1 0801902 18178 7, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35779]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0443-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0443-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39911]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 2 0801902 17207 9, (01) 2 0801902 17207 2, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33712]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0444-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 29 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0444-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27968]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 3 0801902 09203 9, (01) 0 0801902 09203 8, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36538]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0445-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0445-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58406]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09205 2, (01) 3 0801902 09205 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35778]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0446-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0446-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33697]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 04341 2, (01) 3 0801902 04341 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[33676]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0447-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 39 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0447-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21817]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09217 5, (01) 3 0801902 09217 6, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35339]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0448-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 112 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0448-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21820]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35913]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0449-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0449-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28003]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35796]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0450-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 48 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0450-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16651]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09218 2, (01) 3 0801902 09218 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32782]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0451-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0451-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9951]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09219 9, (01) 3 0801902 09219 0, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35936]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0452-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 127 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0452-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51855]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 04342 9, (01) 3 0801902 04342 0, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36146]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0453-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0453-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4715]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09172 7, (01) 3 0801902 09172 8, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35724]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0454-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 15 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0454-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9947]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09173 4, (01) 3 0801902 09173 5, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36466]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0455-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0455-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16659]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09177 2, (01) 3 0801902 09177 3, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35827]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0456-2023
Initiated October 17, 2022
Classification Class I
Status Ongoing
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0456-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39912]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information UDI/DI (01) 0 0801902 09178 9, (01) 3 0801902 09178 0, All Lot/Serial Numbers
Distribution pattern Worldwide
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36151]
FDA event record
· Exact recall-number query on openFDA
