Medtronic Emergency Response Systems, Inc. LIFEPAK 500 AED. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LIFEPAK 500 AED.
Brand
Medtronic Emergency Response Systems, Inc.
Lot Codes / Batch Numbers
Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX
Products Sold
Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX
Medtronic Emergency Response Systems, Inc. is recalling LIFEPAK 500 AED. due to Potential to not detect patients at the low end of the patient impedance range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential to not detect patients at the low end of the patient impedance range.
Recommended Action
Per FDA guidance
On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On 4/22/05 the firm issued another letter, via certified mail return receipt, expanding their recall. Letter was issued to all customers affected by the expansion of the recall. On 4/22/05 the firm issued a press release advising of the expansion of the recall. The firm's web site also provides a listing of affected units.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026