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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DPL

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 Class 2 Device Recall Medtronic DPL see related information
Date Posted March 05, 2013
Recall Status1 Terminated on November 21, 2013
Recall Number Z-0908-2013
Recall Event ID 64417
510(K)Number K120988  K842375 
Product Classification venous cannula - Product Code DWF
Product Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures.

Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.

Code Information Model Catalog# Lot
67312 6731210NO 2012090293
67312 6731210NO 2012090294
67312 6731210NO 2012090337
67312 6731210NO 2012100039
67312 6731210NO 2012100086
67312 6731210NO 2012100087
67312 6731210NO 2012100161
67312 6731210NO 2012110326
67312 6731210NO 2012110767
67312 6731210NO 2012110899
67312 6731210NO 2012111721
67314 6731410NO 2012090416
67314 6731410NO 2012090435
67314 6731410NO 2012090571
67314 6731410NO 2012090572
67314 6731410NO 2012100040
67314 6731410NO 2012100041
67314 6731410NO 2012100107
67314 6731410NO 2012101346
67314 6731410NO 2012110007
67314 6731410NO 2012110008
67314 6731410NO 2012110327
67314 6731410NO 2012111419
67314 6731410NO 2012111420
67314 6731410NO 2012120019
67316 6731610NO 2012090239
67316 6731610NO 2012090389
67316 6731610NO 2012090854
67316 6731610NO 2012091024
67316 6731610NO 2012110030
67316 6731610NO 2012110144
67316 6731610NO 2012110394
67316 6731610NO 2012110395
67316 6731610NO 2012110396
67318 67318 2012110850
67318 67318 2012110851
67318 67318 2012111013
67318 67318 2012111789
67318 67318 2012120328
67318 67318 2012120330
67318 67318 2013010932
67318 67318 2013010933
67318 67318 2013011226
67320 67320 2012121379
67320 67320 2012121629
67320 67320 2013010002
67320 67320 2013010105
69312 6931210NO 2012090236
69312 6931210NO 2012110010
69312 69312INK 2012090296
69312 69312INK 2012100905
69312 69312INK 2012110251
69312 69312INK 2012110252
69314 6931410NO 2012090855
69314 6931410NO 2012091222
69316 6931610NO 2012090240
69318 69318 2012111225
69318 69318 2013010966
69320 69320 2012121408
69320 69320 2013010003
69322 69322 2012111723
69322 69322 2012120118
69322 69322 2012120513
69322 69322 2013010812
69322 69322 2013010935
69324 69324 2012121060
69324 69324 2012121061
69324 69324 2012121062
69324 69324 2012121148
69324 69324 2012121149
69324 69324 2012121362
69328 69328 2012110184
69328 69328 2012120660
69328 69328 2012120661
69328 69328 2012120992
69328 69328 2012121004
69328 69328 2012121005
69328 69328 2012121006
69328 69328 2012121150
69328 69328 2012121192
69328 69328 2012121193
69328 69328 2012121364
69328 69328 201301C189
69331 69331 2012121063
69331 69331 2012121064
69331 69331 2012121151
69331 69331 2012121382
69331 69331 2013010224
69331 69331 2013010437
69331 69331 2013010438
69331 69331 2013010510
69331 69331 2013010511
CB67314 CB67314 206409412
CB67318 CB67318 206513557
CB67318 CB67318 206642303
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact
763-526-6000
Manufacturer Reason
for Recall
Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated February 19, 2013. The letter described the problem and the product involved in the recall. Advised consignees to quarantine affected product, and return the product to Medtronic. Requested consignees the complete and return the attached Customer confirmation certificate. If product has been forwarded to another facility, requested consignees to notify the facility of the issue.
Quantity in Commerce 13,691 (6711 USA; 6980 OUS)
Distribution Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = DLP, INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC INC.
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