Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PSW 1203.U/1 Recalled by BIOTRONIK, Inc. Due to Ventricular packing: LV software programming versions for BIOTRONIK...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BIOTRONIK, Inc. directly.
Affected Products
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Quantity: 768 units (software)
Why Was This Recalled?
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BIOTRONIK, Inc.
BIOTRONIK, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report