Medtronic Perfusion Systems DLP Pressure Sets Recall: Small Pinholes in Packaging
Medtronic Perfusion Systems recalls DLP Pressure Disposable Pressure Display Sets with small pinholes in sterile pouch packaging. Seven product models affected. No remedy specified.
Lower-risk recall
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Contact the company
What happened, in plain English
Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets that have small pinholes in the sterile packaging. This could lead to contamination of the medical device during surgery. The recall affects seven different product models with specific lot numbers. Read more at govinfonow.com/recall/73637-medtronic-perfusion-systems-dlp-pressure-sets-recall-small-pinholes-in.
Source Summary by GovInfoNow · govinfonow.com/recall/73637-medtronic-perfusion-systems-dlp-pressure-sets-recall-small-pinholes-in · Updated September 22, 2026 · FDA enforcement record: FDA #Z-2768-2017
Cite this page
“Medtronic Perfusion Systems DLP Pressure Sets Recall: Small Pinholes in Packaging.” GovInfoNow, updated September 22, 2026. https://govinfonow.com/recall/73637-medtronic-perfusion-systems-dlp-pressure-sets-recall-small-pinholes-in. Based on FDA recall #Z-2768-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2768-2017%22&limit=1).
Why it’s dangerous
Small pinholes in the sterile packaging could allow contaminants to enter the device during surgery. This might lead to infection or other complications if the device is used without proper sterility. However, the packaging issue does not affect the device's functionality.
Who’s affected
Patients undergoing cardiopulmonary bypass surgery who use these specific DLP Pressure Display Sets. The risk is low as the pinholes are in the packaging, not the device itself.
How to tell if you have this one
Check for model numbers 61000 or 62000 with specific lot numbers listed in the recall notice. The product is used during cardiopulmonary bypass surgery to monitor blood pressure.
- Brand
Medtronic Perfusion Systems- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
| Recall number | Product, codes & lots |
|---|---|
| Z-2764-2017 | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery; Model No. 11001G; Product UPN 20613994918554; Lot No. 2016020769, 2016030796, 2016040778, 2016060872, 2016061425, 2016070500, 2016081190, 2016090516, 2016091016, 2016110504, 2016120414, 2017010236, 2017011281, 2017030506. |
| Z-2765-2017 | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae; Model No. 13001; Product UPN 20613994677611; Lot No. 2016020795, 2016030222, 2016030813, 2016031019, 2016040411, 2016040614, 201604C004, 2016050516, 2016050769, 2016051176, 2016060227, 2016061042, 2016061440, 2016070193, 2016070921, 2016070922, 2016080373, 2016090545, 2016091365, 2016100614, 2016101189, 2016101190, 2016110125, 2016110825, 2016111024, 2016111026, 201612C046, 2017010914, 2017010915, 2017020855, 2017020856, 2017021022, 201702C012, 2017030536, 2017031116, 2017040101. |
| Z-2766-2017 | DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours; Model No. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113. |
| Z-2767-2017 | DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.; Model No. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714. |
| Z-2768-2017 | DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.; Model No. 61000: Product UPN: 20613994846604: Lot No. 2016020865, 2016030859, 2016031538, 2016040539, 2016040859, 2016050268, 2016050556, 2016051179, 201605C063, 201605C064, 201605C065, 201605C066, 201605C067, 201605C068, 201605C069, 2016060275, 2016060525, 2016060896, 2016060897, 2016061082, 2016061083, 2016061084, 2016061476, 2016061477, 2016061478, 2016061479, 2016061480, 2016070727, 2016070744, 2016070753, 2016070962, 2016070963, 201607C046, 201607C047, 2016080349, 2016081585, 2016081586, 2016081587, 2016090237, 2016090593, 2016090594, 2016091409, 2016091410, 2016100571, 2016100572, 2016100875, 2016100876, 2016110851, 2016110852, 2016111130, 2016111131, 2016111132, 2016111133, 2016120836, 201612C037, 2017010052, 2017020120, 2017020122, 2017021065, 2017021066, 2017030114, 2017030115, 2017030116, 2017030117, 2017030118, 2017030119, 2017030595, 2017030951, 2017031135, 201703C055. Model 62000: Product UPN: 20613994846642: Lot No. 2016040236, 2016040540, 2016041196, 2016051245, 201605C015, 201605C016, 2016060226, 2016060526, 2016060899, 2016061085, 2016061086, 2016061482, 2016070542, 2016070964, 2016070965, 2016080350, 2016081588, 2016081589, 2016091146, 2016100654, 2016110453, 2016110854, 2016120837, 2017010583, 2017010945, 201701C037, 2017021067, 2017021068, 2017030596, 201703C104, 2017040147. |
What to do — step by step
Check Product Details
Review the model number and lot numbers provided in the recall notice to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2768-2017 (June 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2768-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 22, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.