The Recall Desk
HighFDA (Devices)·Z-1401-2024·Announced 2024-04-10

Cardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect

Terumo is recalling 20,533 cardiovascular procedure kits due to a pressure relief valve that opens at incorrect pressure (200-300 mmHg instead of 400 mmHg). The defect could cause myocardial tissue damage during cardiac surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a cardiovascular device with a mechanical defect that could cause myocardial damage during critical cardiac procedures. Although no illnesses or injuries are reported in the source, the potential for serious harm in a high-risk surgical setting warrants a High severity rating.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling cardiovascular procedure kits due to a defective pressure relief valve. The recalled kits include 20,533 units distributed worldwide, including the United States, Canada, Chile, Colombia, Mexico, South Korea, Taiwan, and Thailand.

The pressure relief valve in these kits opens at approximately 200-300 mmHg instead of the intended 400 mmHg. This defect could allow excessive pressure to build during cardiac surgery, potentially causing myocardial (heart muscle) tissue damage.

Patients undergoing cardiac procedures using these defective kits could be at risk. Damage to heart muscle tissue may require surgical, medical, or pharmacological intervention.

The recalled product

Product
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiovascular Surgery Equipment
Hazard
  • valve-malfunction
  • pressure-relief-defect
  • myocardial-damage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ADULT-SSOCIAL-EL SALVADOR PAC 00699753517233 0000452207 65167-06
  • VAMC SF TUBING PACK 00699753487833 0000329895 66154-01
  • PED CPG BT MUF LINE 00699753510548 303110004 66312
  • RX25 NON X-COATED PACK 00699753493261 0000320596 0000329321 66503-02
  • ADULT PACK ROSALES FX25RE 00699753529069 0000450368 66650
  • AR CHILDRENS HYPO/INFANT SET 00699753510265 0000444141 0000457866 70188-05
  • COATED CUSTOM INFANT PACK 00699753461970 0000439896 70638-07
  • NEONATAL PACK 00699753508262 0000326891 0000326892 0000450287 71432-02
  • FX PEDIATRIC PACK WITH NO OXY 00699753501515 0000328612 71546-02
  • VAMC-SAN ANTONIO 00699753490079 249107214 71733-02
  • X-COATED PUMP AND TABLE PACK 00699753516182 0000309060 73346-01
  • MEMORIAL HERMAN SMALL 00699753481664 0000453291 0000453331 73568-01
  • MEMORIAL HERMAN LARGE 00699753481657 304111470 73776-04
  • SCRIPPS CEREBRAL PERFUSION PK 00699753486669 0000448562 74365
  • X-COATED ADULT PACK 00699753493544 0000448578 0000455771 74502
  • HCG-CARDIOPLEGIA 00699753517400 246105001 74873
  • X-COATED FX HEART PACK 00699753529076 0000440668 0000459155 74972-01
  • X-COATED FX PACK 00699753503076 0000322984 75050-02
  • CENTRAL MAINE 00699753494640 0000326872 246107229 75293-01
  • 1:4 CARDIOPLEGIA PACK 00699753515185 244105866 75409

Distribution

Distributed nationwide across the United States.

Related recalls

Same category