St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as
Check against the official notice below — it lists the full affected range.
St. Jude Medical is advising physicians about 986 Confirm Rx Model DM3500 Insertable Cardiac Monitoring devices that were exposed to sub-freezing temperatures during the supply chain. This cold exposure caused a temporary battery voltage drop in a small number of devices. Although this voltage drop is normal and expected behavior for this battery type and the voltage returns to normal, it causes the device to incorrectly display a low battery indicator.
The affected devices were distributed nationwide across multiple states. Specific serial numbers for affected units have been identified. The recall record does not specify what action an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
Reason for recall: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal. Distribution: U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA, Quantity: 986 Lot/code info: UDI # 05415067027320, serial #: 3183655 3184443 3184389 3199068 3196286 3184694 3190294 3181655 3198025 3190799 3194537 3180006 3192949 3186903 3187101 3196843 3196904 3192584 3197571 3200146 3196834 3199504 3196786 3196805 3195788 3190818 3188329 3201060 3199511 3181484 3198003 3204372 3204525 3204636 3180578 3192047 3197501 3196979 3204026 3190151 3197910 3199061 3187666 3187623 3187958 3199534 3187579 3183988 3191662 3191694 3189471 3189447 3193462 3184495 3182230 3190806 3198544 3195797 3193022 3192891 3186926 3200949 3193007 3199057 3202523 3197153 3193232 3190810 3172363 3190533 3181685 3200755 3195794 3194101 3184565 3198525 3198218 3179589 3193169 3198440 3200149 3182632 3192996 3191110 3190276 3187652 3192050 3193294 3198473 3193374 3182618 3192025 3197500 3195597 3181067 3202827 3180032 3184390 3191088 3199082 3193190 3179542 3196379 3191707 3192522 3192553 3192345 3197952 3201029 3161789 3187614 3192147 3188632 3191329 3192939 3169502 3188423 3198315 3203609 3200671 3203015 3188910 3194498 3200326 3200106 3199163 3188056 3187944 3188081 3180424 3187896 3183112 3180411 3180333 3196930 3187911 3200372 3200308 3187942 3200094 3187574 3187865 3190815 3193199 3187644 3193357 3175355 3178902 3175364 3178951 3178901 3178930 3175392 3190350 3190247 3190365 3184431 3183961 3184510 3184469 3181199 3203028 3193368 3195841 3189780 3188014 3188002 3187994 3191638 3192655 3183842 3184833 3188947 3187854 3186463 3202568 3200110 3186835 3194057 3182576 3188893 3188949 3183736 3189
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.