Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 27, 2026

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Full official product description

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P | Swan-Ganz Pacing Catheter, Models: D200F7; | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

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The last verified facts remain visible. Last successful verification: Jul 30, 2026, 7:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

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Compare the complete identifiers. Name similarity alone is not a confirmed match.

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P; Swan-Ganz Pacing Catheter, Models: D200F7;; plus 1 additional official variants listed below.

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PModel-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371183Z-2203-2026
Swan-Ganz Pacing Catheter, Models: D200F7;Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)53Z-2204-2026
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8,...Model/UDI-DI/Lot(Expiration): 131F7P/00690103000412/65902900(8/1/2026), 65902901(8/3/2026), 65910728(8/2/2026), 65910729(7/29/2026),65910730(7/27/2026), 65910731(7/25/2026), 65910732(7/26/2026), 65910735(7/30/2026), 65910736(8/24/2026), 65910737(7/31/2026), 65916927(8/3/2026), 65916928(8/6/2026), 65916929(8/7/2026), 65916930(8/8/2026), 65916931(8/9/2026), 65916932(8/22/2026), 65916933(8/23/2026), 65944791(8/20/2026),65944792(8/21/2026), 65955857(9/9/2026), 65955858(9/17/2026), 65955859(9/26/2026), 65955860(9/27/2026), 65973739(9/5/2026), 65973740(9/6/2026), 65973741(9/7/2026), 65973742(9/10/2026), 65988571(9/28/2026), 65997478(9/16/2026), 65997479(9/17/2026), 65997481(9/19/2026), 65997482(9/20/2026), 66010504(9/10/2026), 66010505(9/11/2026), 66010506(9/12/2026), 66010507(9/13/2026), 66010508(9/14/2026), 66023074(9/30/2026), 66033088(10/5/2026), 66048930(10/9/2026), 66057629(10/6/2026), 66057630(10/8/2026), 66057944(10/15/2026), 66057945(10/17/2026), 66061552(10/24/2026), 66074999(10/4/2026), 66075318(11/19/2026), 66104892(10/21/2026), 66104893(10/22/2026), 66104894(10/23/2026), 66104895(11/13/2026), 66108277(11/15/2026), 66118638(11/22/2026), 66120310(10/29/2026), 66120312(10/30/2026), 66120313(10/31/2026), 66127027(11/15/2026), 66127028(11/20/2026), 66132570(11/21/2026), 66132571(11/25/2026), 66132572(11/27/2026), 66140447(11/2/2026), 66140448(11/5/2026), 66140449(11/6/2026), 66140450(11/7/2026), 66142269(11/28/2026), 66142274(11/29/2026), 66151008(12/20/2026), 66160820(11/30/2026), 66160821(12/3/2026), 66160822(12/4/2026), 66160823(12/5/2026), 66174935(12/6/2026), 66186389(12/9/2026), 66186390(12/10/2026), 66186391(12/11/2026), 66186393(12/19/2026), 66214346(12/12/2026), 66214347(12/17/2026), 66214348(12/13/2026), 66214349(12/16/2026), 66225263(1/24/2027), 66230833(1/27/2027), 66230834(1/28/2027), 66231174(1/29/2027), 66236300(2/3/2027), 66243301(1/30/2027), 66243302(2/1/2027), 66254697(2/4/2027), 66254698(2/10/2027), 66273573(2/11/2027), 66273574(2/12/2027), 66283862(2/8/2027), 66296222(3/5/2027), 66315689(3/6/2027), 66351811(3/8/2027), 66351812(3/11/2027), 66351813(3/12/2027), 66378395(3/13/2027), 66378396(3/18/2027), 66384489(3/18/2027), 66414674(3/22/2027), 66438179(4/3/2027), 66438197(4/12/2027), 66438198(5/24/2027), 66438199(5/27/2027), 66438200(4/10/2027), 66439368(3/26/2027), 66439369(3/31/2027), 66439370(4/2/2027), 66439371(4/7/2027), 66439372(4/9/2027), 66488597(5/28/2027), 66521743(4/16/2027), 66529338(4/15/2027), 66529339(4/21/2027), 66529340(4/22/2027), 66529341(4/23/2027), 66529345(5/23/2027), 66544240(4/24/2027), 66594945(5/14/2027), 66597237(4/29/2027), 66597238(4/30/2027), 66597239(5/10/2027), 66601166(5/2/2027), 66601167(5/8/2027), 66601168(5/12/2027), 66601169(5/13/2027), 66601170(5/14/2027), 66601171(5/29/2027), 66642726(5/9/2027), 66692566(6/6/2027), 66704724(6/4/2027), 66710839(6/2/2027), 66710840(6/3/2027), 66739812(6/13/2027), 66739813(6/18/2027), 66739814(6/17/2027), 66739910(6/24/2027), 66739911(7/17/2027), 66739912(7/9/2027), 66739913(6/16/2027), 66739916(6/23/2027), 66740114(7/17/2027), 66758828(7/10/2027), 66767282(6/28/2027), 66769651(7/18/2027), 66782067(7/21/2027), 66826029(7/23/2027), 66826030(7/24/2027), 66832079(7/25/2027), 66844048(7/31/2027), 66873884(8/2/2027), 66873885(8/5/2027), 66873886(8/18/2027), 66895223(8/20/2027), 66938771(8/22/2027), 66938772(8/26/2027), 66938773(8/27/2027), 66964710(9/1/2027), 66964711(9/4/2027), 66982688(9/26/2027), 67025469(10/20/2027), 67047800(10/17/2027), 67047801(10/21/2027), 67068446(10/28/2027), 67092101(10/28/2027), 67098252(10/30/2027), 67098253(11/3/2027), 67199591(11/12/2027), 67199595(11/13/2027), 67199596(11/11/2027), 67199617(11/21/2027), 67199618(11/22/2027), 67217934(1/7/2028), 67217935(12/4/2027), 67266297(1/12/2028), 67275624(12/20/2027), 67275626(12/3/2027), 67322713(1/13/2028), 67322714(1/16/2028), 67357488(1/29/2028), 67395549(2/5/2028), 67395555(1/28/2028), 66739917(6/12/2027); 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2What is the risk?

The agency's statement is shown without a site-authored severity score.

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.