St Jude Medical Inc.: 23 recalls on record

Recalls filed with 1 agency: FDA (23).

First recall on record: January 9, 2013. Most recent: August 14, 2019.

Risk classification: Class I: 4 · Class II: 18 · Class III: 1

Most recent recalls

DateAgencyProduct
August 14, 2019FDAELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)Z-2073-2019
August 14, 2019FDAELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 054147345075…Z-2074-2019
August 14, 2019FDAELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)Z-2071-2019
July 4, 2018FDAMerlin PCS programmer (Model # 3650), Software (Model # 3330)Z-2329-2018
July 4, 2018FDAUnify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231…Z-2326-2018
October 25, 2017FDAPM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage…Z-0034-2018
October 25, 2017FDAPM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are impla…Z-0035-2018
October 25, 2017FDAAssurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Num…Z-0030-2018
October 25, 2017FDAMerlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Ca…Z-0032-2018
October 25, 2017FDAInfinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models …Z-0023-2018
October 25, 2017FDAAssurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse genera…Z-0031-2018
October 25, 2017FDAMerlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX115…Z-0033-2018
July 19, 2017FDAProclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product U…Z-2692-2017
July 19, 2017FDAInfinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage…Z-2693-2017
July 19, 2017FDAInfinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: …Z-2695-2017
July 19, 2017FDAProclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product U…Z-2691-2017
July 19, 2017FDAInfinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: …Z-2694-2017
July 19, 2017FDAInfinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: …Z-2696-2017
May 18, 2016FDAEllipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411…Z-1632-2016
October 8, 2014FDAPercutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the S…Z-2719-2014
October 8, 2014FDAPercutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the S…Z-2718-2014
February 20, 2013FDASt. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model …Z-0763-2013
January 9, 2013FDAFast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, R…Z-0617-2013

Questions about this company

How many recalls does St Jude Medical Inc. have?
Recalert has 23 U.S. recalls on record for St Jude Medical Inc., published between January 9, 2013 and August 14, 2019.
What was the most recent St Jude Medical Inc. recall?
FDA recall Z-2073-2019, published August 14, 2019: ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Which agencies have handled St Jude Medical Inc. recalls?
St Jude Medical Inc. appears as the recalling firm in recalls from: FDA (23).

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