Agency classClass IIOur severity:Severe FDA (Devices)·Z-1838-2018·Announced 2018-05-23

COVIDIEN Medtronic Recalls VATS Lobectomy Kits Due to Missing Sled Component

COVIDIEN Medtronic is recalling 171,271 VATS lobectomy kits because the device may be missing a sled component. This defect can cause failure to form a staple line, leading to bleeding or leakage during surgery.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is FDA Class II, but the hazard involves a potential for serious injury (bleeding or leakage of luminal contents) due to device failure. This aligns with the Severe category criteria for significant injury reports or risk-of-harm products where the consequence is serious, even if no specific illness count is provided.

Plain-English summary

COVIDIEN Medtronic is voluntarily recalling 171,271 units of the KIT4184 APEN LOBECTOMY KIT X0 and BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII. The affected products are Endo GIA universal and Endo GIA universal XL staplers used for lobectomy procedures. The recall covers devices distributed worldwide and within the United States nationwide.

The recall was initiated because the device may be missing a sled component. This specific component is responsible for staple deployment during the surgical procedure. If the sled is absent, the stapler may fail to form a proper staple line when tissue is divided.

This failure can result in serious complications for patients, including bleeding or leakage of luminal contents. The affected lot numbers are 0214962218, 02148663335, 0214993030, and 0215178525. Healthcare providers should inspect their inventory for these specific lot numbers and remove any affected units from use.

The recalled product

Product: (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers…
Manufacturer: COVIDIEN MEDTRONIC
Category: Medical Device — Surgical Stapler Kit
Hazard: device-malfunction
bleeding
leakage
Affected units: 171,271

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 (3)

(1)Lot Number: 0214962218 (2) Lot Numbers: 02148663335
0214993030
0215178525

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 40 recalled by COVIDIEN MEDTRONIC 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 40 products in this recall →

Same manufacturer · COVIDIEN MEDTRONIC

See all →

Severe
Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
Severe
Medtronic Endo GIA Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
Severe
Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
Severe
Medtronic Endo GIA Stapler Recall Due to Missing Sled Component
FDA (Devices) · 2018-07-25
Severe
Endo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25

Same hazard · device malfunction