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Terminated

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.

FDA Recall Z-0763-06 · Posted 2006-04-13

Recalling FirmMedtronic Cardiac Surgery Technologies
Recall StatusTerminated
Product CodeFZP
Date Initiated2005-09-01
Date Terminated2007-04-01
Product Quantity3383

Reason for Recall

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.

Firm Action

A letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031623MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIESCoalescent Surgical · 2003-07-03K024366COALESCENT SURGICAL U-CLIP AND ACCESSORIESCoalescent Surgical · 2003-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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