DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
What this means for you
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: The recall is classified as FDA Class II and involves the use of a medical device for an uncleared function (neuromonitoring), which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
DePuy Spine, Inc. is recalling 102 units of the PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated, and Holding Clip. These medical devices are intended for the sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
The recall was initiated because the dilators and holding clip were used for a secondary function of neuromonitoring. The source text states that the devices are not 510(k) cleared for this specific use. The agency has classified this recall as Class II.
The affected units were distributed nationwide, including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY. The product code is 287105014. Healthcare providers should stop using these devices for neuromonitoring and contact DePuy Spine for instructions on return or replacement.
The recalled product
- Product
- PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
- Manufacturer
- DePuy Spine, Inc.
- Hazard
- Affected units
- 102
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 (1)
- 287105014
Distribution
Part of a larger recall action
This product is one of 5 recalled by DePuy Spine, Inc. 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.
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