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U.S. Department of Health and Human Services

Class 2 Device Recall SPYDER Anastomotic Device

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 Class 2 Device Recall SPYDER Anastomotic Devicesee related information
Date Initiated by FirmSeptember 01, 2005
Date PostedApril 13, 2006
Recall Status1 Terminated 3 on April 01, 2007
Recall NumberZ-0763-06
Recall Event ID 33341
510(K)NumberK024366 K031623 
Product Classification Clip, Implantable - Product Code FZP
ProductMedtronic 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.
Code Information All units with Use Before Dates earlier than June, 2007.
FEI Number 3003368396
Recalling Firm/
Manufacturer		 Medtronic Cardiac Surgery Technologies
7601 Northland Dr N
Minneapolis MN 55428-1088
For Additional Information ContactFrancis Kim
763-391-9030
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionA letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005.
Quantity in Commerce3383
DistributionNationwide (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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FZP
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