Recall events
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Event 95186
Event summary
Timeline bucket July 18, 2024
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Boston Scientific Corporation
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
5 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 5
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Z-3147-2024
Recall number Z-3147-2024
Initiated July 18, 2024
Classification Class II
Status Ongoing
Quantity 89 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3147-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51649]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
Distribution pattern US, Colombia, Philippines, Russia
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[4398]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Z-3148-2024
Recall number Z-3148-2024
Initiated July 18, 2024
Classification Class II
Status Ongoing
Quantity 32 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3148-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57736]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
Distribution pattern US, Colombia, Philippines, Russia
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[4627]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Z-3149-2024
Recall number Z-3149-2024
Initiated July 18, 2024
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3149-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57735]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information GTIN/UDI 0871472932337, Lot # 33550953, exp. 03/04/2027
Distribution pattern US, Colombia, Philippines, Russia
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[4467]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
Z-3150-2024
Recall number Z-3150-2024
Initiated July 18, 2024
Classification Class II
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3150-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57737]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information GTIN/UDI 0871472913774, Lot # 33512377, exp. 02/26/2027
Distribution pattern US, Colombia, Philippines, Russia
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[4397]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Z-3151-2024
Recall number Z-3151-2024
Initiated July 18, 2024
Classification Class II
Status Ongoing
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3151-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9924]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information GTIN/UDI 0871472904856, Lot # 33751204, exp. 04/03/2027
Distribution pattern US, Colombia, Philippines, Russia
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[4710]
FDA event record
· Exact recall-number query on openFDA
