UPDATED Feb. 12, 2015, with new information from Medtronic.
Medtronic (NYSE:MDT) subsidiary Covidien issued a Class I recall of its Trellis 6 and Trellis 8 clot-busting infusion devices due to a labeling snafu.
The Trellis devices are designed to isolate blood clots between a pair of catheterized balloons; medication is then injected into the space between the balloons to dissolve the clot or reduce it for removal, the FDA said.
Covidien said it hasn’t received any reports of injury related to the miscue, which it said it learned of from customer reports.
The recall of 1,126 Trellis devices, distributed between June 6 and Nov. 13, 2014, was caused by a manufacturing error in which the balloon inflation ports to be mislabeled, according to the safety watchdog.
"This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs," the FDA said. "Depending upon the size of these clots, there is the possibility of serious patient injury or death."
Covidien sent an urgent product recall letter to customers Dec. 15, the agency said, asking them to discontinue use of the affected devices and return them to the company’s Plymouth, Minn., facility.
Here is a list of the products being recalled:
Product | Model | Lot Numbers |
---|---|---|
Trellis 6 | Model BVT608010 | 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740 |
Trellis 6 | Model BVT608030 | 9853331, 9887597, 9887695, 9887757, 9932042 |
Trellis 6 | Model BVT612010 | 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423. |
Trellis 6 | Model BVT612030 | 9854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687 |
Trellis 8 | CVT808015 | 9895996, 9904675, 9910270, 9911926, 9912084, 9912200, 9922490, 9922584, 9922597, 9922601, 9922604, 9922606, 9922617, 9922620, 9922624, 9922635, 9923420, 9924840, 9928078, 9932274, 9933341, 9933774, 9933839, 9933934, 9934029, 9934440, 9934633, 9934686, 9936420, 9937544, 9937660, 9942679, 9943032, 9945436, 9948145, 9949409, 950000, 9950703 |
Trellis 8 | CVT808025 | 9904237, 9906429, 9910270, 9912003, 9912117, 9912261, 9922644, 9922658, 9922661, 9922663, 9922739, 9922862, 9922868, 9923391, 9923401, 9923405, 9923428, 9923437, 9923454, 9924796, 9924802, 9924826, 9924847, 9924853, 9928334, 9928629, 9929004, 9929248, 9929344, 9933577, 9933797, 9933903, 9934553, 9934772, 9935134, 9935174, 9935241, 9935245, 9935471, 9935523, 9935757, 9935889, 9936140, 9936631, 9936680, 9936702, 9936735, 9937706, 9938500, 9938960, 9939918, 9939985, 9940234, 9940687, 9940916, 9948001, 9948544, 9949603, 9950150, 9950722, 9951391, 9952404, 9952785, 9952844, 9959913 |
Trellis 8 | CVT812015 | 9904401, 9904676, 9910934, 9912387, 9922742, 9922793, 9922886, 9922892, 9922902, 9922904, 9922917, 9923224, 9923226, 9923237, 9923268, 9923275, 9923398, 9923446, 9923453, 9924832, 9932594, 9933474, 9933813, 9933924, 9934192, 9934730, 9936820, 9937095, 9937806, 9942701, 9943235, 9945140 |
Trellis 8 | CVT812025 | 9910342, 9911492, 9911683, 9911812, 9912503, 9922498, 9922750, 9922753, 9922873, 9922911, 9923246, 9923403, 9923404, 9923409,, 9923426, 9923442, 9923450, 9923457, 9924848, 9925351, 9933666, 9934311, 9934575, 9934700, 9935143, 9935199, 9935494, 9935636, 9935900, 9936109, 9936173, 9936570, 9936597, 9936848, 9937896, 9937968, 9938060, 9938219, 9938831, 9938896, 9941711, 9945304, 9947559, 9948088, 9949321, 9949934, 9950324, 9951247, 9951521, 9952927, 9957277, 9957530, 9959854, 9959944, 9960241, 9960324, 9960635, 9960807, 9961583, 9961682, 9962504, 9963558, 9964120, 9964347, 9964448, 9965066, 9965335, 9966329, 9966429, 9966999, 9967656, 9967694, 9968180, 9969396, 9972428, 9972429, 9972819, 9972867, 9972966 |
Trellis 8 | EVT808015 | 9912933, 9913003, 9913878, 9928819, 9929499, 9929826, 9929913, 9929937, 9929971, 9929980, 9930297, 9930464, 9930797, 9930951, 9931141, 9931509, 9931544, 9955126, 9955275, 9956434, 9970652, 9929826, 9930951, 9955126, 9955275, 9956347 |
Trellis 8 | EVT808025 | 9912629, 9913219, 9913619, 9913647, 9913792, 9928202, 9928286, 9928957, 9929625, 9929921, 9929942, 9929975, 9929984, 9930119, 9954578, 9954720, 9955164, 9955302, 9956600, 9957360, 9966889, 9968025, 9970097, 9954578, 9955164 |
Trellis 8 | EVT812015V01 | 9928226, 9928916, 9931680, 9954559, 9954683, 9955186, 9956478, 9956505, 9956660, 9961108, 9966680, 9966940, 9967242, 9968054, 9968734, 9969632, 9954559, 9966680 |
Trellis 8 | EVT812025V01 | 9929653, 9953991, 9954138, 9928255, 9929653, 9929681, 9930088, 9954138, 9954398, 9954500, 9954604, 9955002, 9955236, 9957446, 9959050, 9959087, 9960088, 9960218, 9961172, 9965700, 9965782, 9967620, 9967622, 9975240, 9975547, 9977238, A000273 |