DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pr...
FDA Device Recall #Z-2768-2017 — Class II — June 22, 2017
Recall Summary
| Recall Number | Z-2768-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Perfusion Systems |
| Location | Brooklyn Park, MN |
| Product Type | Devices |
| Quantity | 63053 (48180 US) (14873 OUS) |
Product Description
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Reason for Recall
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Distribution Pattern
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.
Lot / Code Information
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.
Other Recalls from Medtronic Perfusion Systems
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1473-2026 | Class II | Octopus Nuvo Tissue Stabilizer, disposable tiss... | Jan 13, 2026 |
| Z-0539-2026 | Class II | Medtronic HR-ACT (High Range Activated Clotting... | Oct 20, 2025 |
| Z-0509-2026 | Class II | MC3 VitalFlow Console, REF 58100; Blood pump of... | Oct 3, 2025 |
| Z-0487-2026 | Class II | Affinity NT Oxygenator, Oxygenator with Balance... | Sep 12, 2025 |
| Z-2481-2025 | Class I | DLP Left Heart Vent Catheter Malleable body and... | Aug 6, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.