The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0957-2022·Announced 2022-04-27

Abbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices

Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall affecting a critical medical device used in cardiac ablation procedures. No illnesses or injuries have been reported; however, the preprogrammed software disables device functionality, creating a risk of harm if non-functional devices are inadvertently used in patient procedures.

Plain-English summary

Abbott has recalled 588 TactiCath Sensor Enabled Contact Force Ablation Catheters, Model A-TCSE-DD, due to a manufacturing defect. The devices were preprogrammed in their memory (EEPROM) with a "First Use Date" that disables the functionality of the single-use catheter.

The recalled devices were distributed worldwide, including nationwide throughout the United States. International distribution included Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and the United Kingdom. Affected lot numbers are: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547.

The TactiCath is an ablation catheter used in cardiac electrophysiology procedures. Healthcare organizations should verify lot numbers of devices in inventory against the recalled lots to prevent use of non-functional devices.

The recalled product

Product
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Manufacturer
Abbott
Category
Medical Device — Ablation Catheter
Hazard
Affected units
588

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Lot numbers: 8181068
  • 8182131
  • 8198290
  • 8198350
  • 8200249
  • 8200300
  • 8201447
  • 8202313
  • 8203518
  • 8203835
  • 8203857
  • 8205760
  • and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Abbott under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Abbott

See all →

Same hazard · device malfunction

See all →

Similar recalls