FDA Medical Device Recalls (openFDA)
Medtronic Vascular: Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
- Recall number
- Z-2754-2011
- Recalling firm
- Medtronic Vascular
- Product
- Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
- Status
- Terminated
- Initiated
- 2011-06-08
- Posted
- not on file
- Terminated
- 2012-04-17
- Reason
- Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve
- Root cause
- Labeling Change Control
- Action
- The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.
- Quantity
- 5 units
- Distribution
- Nationwide distribution: USA including states of: CA, FL, and MA.
- Lot, serial or model codes
- Lot # : 0005199588
- 510(k) numbers
- ["K010579","K990707"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- 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