Reported Nov 15, 2023 · Ongoing

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary…

St. Jude Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: St. Jude Medical · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424

Is this the product you have?

  • CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Lot codes and dates
  • Model Number CM1100
  • UDI/DI05414734509800
  • Serial Numbers

    2,712 of 2,712 codes

    • P150800220
    • P150800222
    • P150800226
    • P150800240
    • P150800242
    • P150800245
    • P150800246
    • P150800249
    • P150800262
    • P150800263
    • P150800264
    • P150800265
    • P150800266
    • P150800267
    • P150800268
    • P150800273
    • P150800277
    • P150900313
    • P150900315
    • P150900318
    • P150900319
    • P150900322
    • P150900333
    • P150900334
    • P150900335
    • P150900337
    • P150900343
    • P150900344
    • P150900349
    • P150900350
    • P160100406
    • P160100410
    • P160100412
    • P160100414
    • P160100416
    • P160100419
    • P160100422
    • P160200429
    • P160200434
    • P160200435
    • P160200440
    • P160200442
    • P160200451
    • P160200452
    • P160200453
    • P160200456
    • P160200459
    • P160200464
    • P160200466
    • P160200469
    • P160200476
    • P160200479
    • P160200480
    • P160200486
    • P160200487
    • P160200488
    • P160200489
    • P160200490
    • P160200493
    • P160200498
Amount recalled
36,153 units

Where it was sold

  • Nationwide

Why it was recalled

Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.