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

Recall number

Z-0535-2018

Recalling firm

Medtronic Perfusion Systems

Product

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

Status

Terminated

Initiated

2018-01-03

Posted

2018-01-30

Terminated

2020-10-05

Reason

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

Root cause

Component change control

Action

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.

Quantity

2914 units

Distribution

DE, IA, CA and Japan

Lot, serial or model codes

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

510(k) numbers

["K171308"]

PMA numbers

not on file

Product code

DWF

Firm FEI

1000116158

Firm city

Brooklyn Park

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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