FDA Medical Device Recalls (openFDA)
St. Jude Medical: St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel.
- Recall number
- Z-2229-2009
- Recalling firm
- St. Jude Medical
- Product
- St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel.
- Status
- Terminated
- Initiated
- 2009-08-17
- Posted
- 2009-09-18
- Terminated
- 2011-12-17
- Reason
- St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
- Root cause
- Error in labeling
- Action
- Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm. Contact your local St Jude Medical representative for further information.
- Quantity
- 490
- Distribution
- Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
- Lot, serial or model codes
- Lot Number: 4219
- 510(k) numbers
- ["K791129"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 2182269
- Firm city
- Minnetonka
- Firm state
- MN
- 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