CLASS III Device recall · Reported 3 Jul 2019 · FDA Enforcement Report

Replacement leadwires with grabber ends recalled by GE Healthcare

GE Healthcare is recalling Replacement leadwires with grabber ends, distributed nationwide in the US. The recall was initiated on 10 May 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesproduct does not have lot or serial codes No GTIN/UDI

Quantity recalled58,045 units (31,108 US; 26937 OUS) in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1877-2019
FDA event ID: 82937
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class III
Status: Terminated
Recall initiated: 10 May 2019
FDA classified: 25 Jun 2019
Reported: 3 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

10 May 2019	Recall initiated by company
25 Jun 2019	Classified by FDA	+46 days
3 Jul 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

Product as listed by the FDA

Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

Where it was distributed

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

Which lots are affected?

product does not have lot or serial codes No GTIN/UDI

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 82937

This product is part of a recall event; the main page for the event is Leadwire sets with snap ends recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019	CLASS III	Leadwire sets with snap ends recalled by GE Healthcare	GE Healthcare	Other	Nationwide
3 Jul 2019	CLASS III	ECG Trunk Cables recalled by GE Healthcare	GE Healthcare	Other	Nationwide
3 Jul 2019	CLASS III	Replacement ECG leadwires with snap ends recalled by GE Healthcare	GE Healthcare	Other	Nationwide
3 Jul 2019	CLASS III	ECG leadwire sets recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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