Custom Packs/Mexico recallZ-0813-2012 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Dec 14, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. Cardiac Rhythm Disease Management or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p
FDA root cause category: Labeling design
What the company is doing
Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
Recall details
- Recall number
- Z-0813-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2011
- Posted by the FDA
- Jan 18, 2012
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Quantity
- 106
- Product code
- DTZ
- FDA submissions
- K891687
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
Product description
Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intersept Custom Tubing Pack with Trillium Biosurface, Sterilized Using Ethylene Oxide, , Model # TL4F71R1. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Model # / Lot # DLP6N48R3 DLP6N48R4 TL4F71R1 11241044 11465359 11799944 11755661 11713167 11713167 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607
Other devices under the same FDA submission
42 devices cleared under K891687 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA CB7X82R4Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J98R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J97R8Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB10W63R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall2 reports
- NA CB4Z27RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB5S68R3Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB6M85R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7D52RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB6Z18R3Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7J45R2Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7N52RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7N54R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 60720).
- Z-0807-2012 · TerminatedMedtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile EO, Nonpyrogenic. Model number #'s : 67312, 67314, 67316, 67318, 67320, 69312, 69314, 6…
- Z-0808-2012 · TerminatedMedtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134,…
- Z-0809-2012 · TerminatedMedtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 67512, 67514, 67516, 67518, 67520, 67522, 67524, 67526, 67528, 67530, …
- Z-0810-2012 · TerminatedMedtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s 68112, 68114, 68116, 68118, 68120, 68122, 68124, 68…
- Z-0812-2012 · TerminatedMedtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116,…
- Z-0814-2012 · TerminatedCustom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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