FDA Medical Device Recalls (openFDA)
St Jude Medical CRMD: Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead
- Recall number
- Z-1482-2012
- Recalling firm
- St Jude Medical CRMD
- Product
- Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead
- Status
- Terminated
- Initiated
- 2012-04-03
- Posted
- 2012-05-03
- Terminated
- 2012-07-17
- Reason
- Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
- Root cause
- Device Design
- Action
- A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774. A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals. A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.
- Quantity
- 101,000 units (59,000 units in US)
- Distribution
- Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Bahrain, Balkan, Baltic, Belarus, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Montenegro, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Serbia Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, US, Venezuela, and Yemen.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- ["P030054/S04","P030054S018"]
- Product code
- NIK
- Firm FEI
- 2017865
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28