Datascope Corporation: 17 recalls on record

Recalls filed with 1 agency: FDA (17).

First recall on record: September 10, 2014. Most recent: November 2, 2022.

Risk classification: Class II: 16 · Class III: 1

Most recent recalls

DateAgencyProduct
November 2, 2022FDALINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic b…Z-0131-2023
September 14, 2022FDAMEGA 8Fr 50cc Intra-Aortic Balloon CatheterZ-1685-2022
September 2, 2020FDADatascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-047…Z-2839-2020
September 2, 2020FDADatascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit …Z-2843-2020
September 2, 2020FDADatascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01…Z-2833-2020
September 2, 2020FDADatascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0…Z-2838-2020
September 2, 2020FDADatascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-…Z-2837-2020
September 2, 2020FDADatascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product U…Z-2842-2020
May 16, 2018FDABEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504Z-1729-2018
May 16, 2018FDABEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622Z-1721-2018
May 16, 2018FDABEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179Z-1712-2018
April 25, 2018FDAIntra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon…Z-1383-2018
May 31, 2017FDASENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Pr…Z-2164-2017
April 19, 2017FDACustom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058…Z-1769-2017
June 22, 2016FDASmall Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioli…Z-2002-2016
June 15, 2016FDAMEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7…Z-1935-2016
September 10, 2014FDALINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge GroupZ-2568-2014

Questions about this company

How many recalls does Datascope Corporation have?
Recalert has 17 U.S. recalls on record for Datascope Corporation, published between September 10, 2014 and November 2, 2022.
What was the most recent Datascope Corporation recall?
FDA recall Z-0131-2023, published November 2, 2022: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Which agencies have handled Datascope Corporation recalls?
Datascope Corporation appears as the recalling firm in recalls from: FDA (17).

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