FDA Medical Device Recalls (openFDA)
Medtronic Cardiac Surgery Technologies: Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis.
- Recall number
- Z-0763-06
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- Product
- Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis.
- Status
- Terminated
- Initiated
- 2005-09-01
- Posted
- 2006-04-13
- Terminated
- 2007-04-01
- Reason
- Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.
- Root cause
- Other
- Action
- A letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005.
- Quantity
- 3383
- Distribution
- Nationwide (AZ, CA, CT, FL, HI, IA, ID, IL, IN, KS, KY, LA, ,MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, TN, TX, UT, WA, WI, WV). Japan, Belgium, Netherlands, Singapore, and Thailand.
- Lot, serial or model codes
- All units with Use Before Dates earlier than June, 2007.
- 510(k) numbers
- K024366, K031623
- PMA numbers
- not on file
- Product code
- FZP
- Firm FEI
- 3003368396
- Firm city
- Minneapolis
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06