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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84521

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 20, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Datascope 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

3 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 3

Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.

Z-0932-2020
Recall number
Z-0932-2020
Initiated
November 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Datascope Corporation
Quantity
102

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Code information

Part Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT

Distribution pattern

US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

device · product 2 of 3

Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

Z-0933-2020
Recall number
Z-0933-2020
Initiated
November 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Datascope Corporation
Quantity
676

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Code information

Part Number: 068400040305 UDI: 10607567106694 (068400040305) Lot Codes: 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, TTQ.

Distribution pattern

US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

device · product 3 of 3

Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

Z-0934-2020
Recall number
Z-0934-2020
Initiated
November 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Datascope Corporation
Quantity
523

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Code information

Part Number: 068400040310 UDI: 10607567107943 (068400040310) Lot Codes: 3000079612, 3000043101, 3000036631, 3000015016, TTP.

Distribution pattern

US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia