Medtronic Custom Perfusion Systems, indicated for use in… recallZ-0535-2018 · Medtronic Perfusion Systems · initiated Jan 3, 2018

Terminated

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 Perfusion Systems 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

Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

FDA root cause category: Component change control

What the company is doing

In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.

Recall details

Recall number: Z-0535-2018
Status: Terminated
Initiated by the company: Jan 3, 2018
Posted by the FDA: Jan 30, 2018
Recalling firm: Medtronic Perfusion Systems
Quantity: 2914 units
Product code: DWF
FDA submissions: K171308
Distribution: DE, IA, CA and Japan

Product description

Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744 b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210767149, 211011818, 211210404, 211243436, 211542842, 211761616 c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361 d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883, 212796215, 213248430, 213583108 e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837 f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103 g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers: 212020797, 212174623, 212193001, 212301586, 212355584, 212428238, 212626142, 212884370, 213001157, 213248459, 213631247, 213672934, 213802501, 214072742, 214093025 h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326 i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954 j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166, 213358174, 213573495, 213623995, 214053395 k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507 l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749 m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers: 211423503, 211443209, 211443210, 211885323, 211991293, 212154744, 212235237, 212274655, 212428312, 212473311, 212671632, 212962650, 213126447, 213292357, 213377926, 213445426, 213494394, 213494396, 213672914, 213906498, 214043035, 214093030 n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742, 211846417, 212235012, 212545229, 212835348 o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066, 212355669, 213001001, 213719738 p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704

Devices named in this recall

13 devices in the FDA device registry whose identifier appears in the recall's code information.

NA HY8M65R2
Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
4 recalls0 reports
NA BB9L72R1
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
3 recalls0 reports
NA CB7X82R4
Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
2 recalls0 reports
Custom Perfusion System HY6Y19R5
Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
2 recalls0 reports
NA BB4B15R13
Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type
2 recalls0 reports
NA BB4B15R14
Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type
2 recalls0 reports
INTERSEPT® 2D25R6
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
1 recall0 reports
NA CB5S68R3
Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
1 recall0 reports
NA TL8W39R6
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
1 recall0 reports
NA CB7X82R5
Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
1 recall0 reports
NA BB9L72R
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
1 recall0 reports
NA 2815R1
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
1 recall0 reports
NA 9M68R
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
1 recall0 reports

Product lines

Other devices under the same FDA submission

97 devices cleared under K171308 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

NA HY2V10R33
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls3 reports
NA HY11B40R1
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls2 deaths2 reports
NA HY7V82R20
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls2 reports
NA HY9R12R13
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls1 report
NA BB10H89R4
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls0 reports
NA HY10G12R7
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls0 reports
NA HY5V41R21
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls0 reports
NA HY7E57R17
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls0 reports
NA HY7W91R22
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls0 reports
NA HY9M47R6
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
1 recall4 reports
NA BB8D44R6
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
1 recall4 reports
NA BB8G43R7
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
1 recall2 reports

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 16, 2026. Text above is shown as published by the FDA.

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