Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A
Medical device recall Z-1401-2024. Published in FDA’s Enforcement Report on Apr 10, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 10, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 20,533 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02 75540-03 75540-05 75572-01 75642-02 75688-01 75790-02 75834-01 75927-01 75959-01 75972-01 76178-01 76273-01 76278-01 76308-01 76326-02 76372-01 76373-01 76374-01 76376-01 76491-01 76732-02 76873-02 77012-02 77127-01 77316-01 77496-01 77502-01 77521-01 77532-01 77655-01 77791-01 B75409 B75410 B75903 B76178 B76278
20,533 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number/Product Name/GTIN/Lot Numbers: 16010 CARDIOPLEGIA SET 4:1 RATIO NO RECIRC 00699753001534 2L05 2L12 2L19 2P19 165720; CARDIOPLEGIA SET 4:1 RATIO16 00699753000278 2K15 2K22 2K29 2L05 2L19 2L26 2M03 2M10 2P19 3A02 62974; CUSTOM…
Every code shown here, 1,998 characters
Product Number/Product Name/GTIN/Lot Numbers: 16010 CARDIOPLEGIA SET 4:1 RATIO NO RECIRC 00699753001534 2L05 2L12 2L19 2P19 165720; CARDIOPLEGIA SET 4:1 RATIO16 00699753000278 2K15 2K22 2K29 2L05 2L19 2L26 2M03 2M10 2P19 3A02 62974; CUSTOM CP50 4:1 CARDIOPLEGIA 00699753454880 0000321897 245106371 302110840 6375; CARDIOPLEGIA SET 4:1 RATIO WITH BRIDGE16 00699753008533 2K15 2K22 2L12 2L19 2L26 2P19 65046-03; PUMP AND TABLE PACK 00699753497092 0000311775 0000311776 243105334 65080-06; ADULT-SSOCIAL-EL SALVADOR PAC 00699753517233 0000452207 65167-06; PUMP & TABLE FX PACK 00699753499348 0000329322 0000329331 0000447522 301104985 303108168 65246; CUSTOM 1:1 CONDUCER / MP4 00699753458147 2M17 2P12 65934-01; UCSD PTE CARDIOFLEX CP 1:4/4:1 00699753500808 0000288968 0000437413 0000452200 242102098 243105189 243105789 246107180 249109155 251109777 65940-01; UCSF ADULT PACK 00699753485297 0000328414 0000331083 243105281 246105282 250107937 66041-01; VAMC SF TUBING PACK 00699753487833 0000329895 66154-01; PED CPG BT MUF LINE 00699753510548 303110004 66312; 4:1 CARDIOPLEGIA SET 00699753489202 0000324255 242103295 249107463 308111832 66342; RX15 NON X-COATED PACK 00699753491533 0000306497 0000306498 0000306499 248105327 301108454 302110899 66388; RX25 NON X-COATED PACK 00699753493261 0000320596 0000329321 66503-02; ADULT PACK ROSALES FX25RE 00699753529069 0000450368 66650; CARDIOPLEGIA 00699753509344 251108577 304110009 304112395 66852; CPG DEL NIDO PANAMA 00699753513716 243999665 246105460 251108579 308112349 70148-02; TOTAL VISION SYSTEM 00699753492615 0000309898 0000440663 302110835 70178-06; AR CHILDRENS HYPO/INFANT SET 00699753510265 0000444141 0000457866 70188-05; UVRMC MEMBRANE PACK 00699753507319 0000306512 0000306513 0000441631 0000450286 250109165 251107206 302110344 70472; COATED CUSTOM INFANT PACK 00699753461970 0000439896 70638-07; COMMUNITY OH 4:1 CARDIO CEN 00699753515789 0000324364 0000440665 0000457895 250107193 251109771 302110814 303111435 70664-02 ; PRESTIGE…
FDA’s list runs to 14,595 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 20, 2024.
- FDA classified it on Mar 29, 2024.
- FDA’s Enforcement Report published it on Apr 10, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Terumo Cardiovascular Systems Corporation, of Ann Arbor, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 14,595 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.