FDA Medical Device Recalls (openFDA)
Guidant Cardiac Surgery: Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
- Recall number
- Z-0612-2007
- Recalling firm
- Guidant Cardiac Surgery
- Product
- Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
- Status
- Terminated
- Initiated
- 2006-12-01
- Posted
- 2007-03-16
- Terminated
- 2007-12-04
- Reason
- Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
- Root cause
- Other
- Action
- The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.
- Quantity
- 57,691 units distributed total
- Distribution
- Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.
- Lot, serial or model codes
- All products with expiry dates of June 2008, lot codes ranging from 4120281 to 6102381. See Below: 4120281 5020781 5051381 5062181 5091481 5110182 6013181 6040581 6062481 6091881 6101881 4120681 5021481 5052381 5072881 5092781 5110381 6020681 6050181 6070581 6091981 6101882 4121581 5031681 5052382 5081081 5092782 5110481 6020682 6050681 6081781 6092581 6102381 5010681 5032181 5061581 5081681 5101881 5120181 6022181 6051881 6081782 6092582 5011881 5040681 5061681 5081781 5101981 5120281 6030681 6052081 6081881 6101181 5012881 5041881 5061781 5081782 5101982 6010481 6030781 6060981 6083081 6101681 5020381 5050281 5062081 5081881 5110181 6011981 6040481 6061981 6083181 6101682
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MWS
- Firm FEI
- 3000719698
- Firm city
- Santa Clara
- 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